Patients over 70 years old are under represented in clinical trials and there are no clear guidelines regarding the use of adjuvant chemotherapy for early breast cancer in this population. Whether CT retains the benefit conferred to younger patients remains uncertain. Moreover, there is extensive data regarding the increasing incidence and severity of side effects, such as myelotoxicity, mucositis and cardiotoxicity, with CT in this population. The efficacy and safety of CT in aged patients have been evaluated in different studies, most of them in haematological malignancy. Clearly, the patients' functional declines with age and the risk for CT toxicity rises with age. There is no standard of care regarding adjuvant chemotherapy for breast cancer in patients older than 70 years old.

This is a pilot study evaluating the feasibility and safety of 6 cycles of capecitabine in patients aged 70 years or more with high-risk early invasive breast cancer who have undergone optimal surgery.

The primary end point is to evaluate the possibility of delivering 6 cycles of capecitabine at the dose of 1000 mg/m² BID days 1 to 14 every 3 weeks, in terms of rate of patients who will receive an acceptable relative dose intensity (RDI).

Secondary end points are safety (including the evaluation of possible impact of treatment on the functional, cognitive and emotional status of the patient) and evaluating if some form of geriatric assessment add any information to the classic "inclusion criteria screening" in terms of prediction of treatment compliance and toxicity.

The study is being conducted at the Jules Bordet Institute. The planned accrual is 43 patients.

Eligibility

Ages Eligible for Study:

70 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Women aged ³70 years

Histologic diagnosis of early breast cancer for which the treating physician considers adjuvant chemotherapy to be beneficial. Recommended situations are for example:

endocrine non responsive (ER- and PgR -) and pT>1 cm, any T if N+ OR

endocrine responsiveness doubtful (ER and/or PgR- or poor [3 to-5 according to Harvey score (12) or £ 30% of positive cells by immunohistochemistry) and other risk factors (pT³2 cm or N+ or G3 or Her-2/neu positive, etc.) OR

clinical and/or ECG evidence of myocardial infarction within the last 12 months;

Coronary artery disease requiring medication.

Absence of any psychological, familial or sociological condition or comorbidities that may affect compliance

Written informed consent obtained according to local ethics committee guidelines -

Exclusion Criteria:

N/A-

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263705